Public Health Watchdog Reports UK Regulators Implement New Measures to Reduce Risk of Transvaginal Mesh Complications

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Public Health Watchdog is informing the public that the UK’s Department of Health, National Health Service (NHS) Commissioning Board and the Medicines and Healthcare products Regulatory Agency (MHRA) are offering better guidance to surgeons using transvaginal mesh implants to treat pelvic organ prolapse. The actions are being taken in an attempt to reduce the risk of serious complications from mesh implants and vaginal tape.

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Some women have experienced some distressing side effects and we are working closely with surgeons and the MHRA to make sure that improvements are made and patients are well informed...

Public Health Watchdog, a media outlet created to protect and warn consumers about the dangers of defective drugs and medical devices, is informing the public about a recent update issued by health regulators in the United Kingdom. According to a media release by the Department of Health, National Health Service (NHS) Commissioning Board and the Medicines and Healthcare products Regulatory Agency (MHRA), surgeons in the UK will have better information on how to reduce the risk of complications associated with transvaginal mesh implants used to treat pelvic organ prolapse.

According to the Department of Health, roughly 15 percent of women report adverse events related to receiving mesh implants for pelvic organ prolapse, a condition that causes pelvic organs to slip out of place due to the weakening of the pelvic muscles. New measures are now being implemented in response to a number of women who report serious injuries after receiving a mesh implant. “These measures will include developing proposals for a registry for implanted vaginal tapes and meshes to help surgeons to compare the outcomes of their treatment, building on the voluntary registries already established by the professional associations.”

Professor Keith Willett, National Clinical Director for Acute Episodes of Care at the NHS Commissioning Board, stated that “Some women have experienced some distressing side effects and we are working closely with surgeons and the MHRA to make sure that improvements are made and patients are well informed about the benefits and potential risks with these procedures.”

In the US, transvaginal mesh implants are approved to treat pelvic organ prolapse and stress urinary incontinence. The U.S. Food and Drug Administration (FDA) has addressed numerous reports of complications linked to the device, such as:

  •     Mesh erosion through the vagina (exposure, extrusion, protrusion)
  •     Pain
  •     Infection
  •     Bleeding
  •     Pain during sexual intercourse (dyspareunia)
  •     Organ perforation
  •     Urinary problems

In a Safety Communication issued last year, the agency warned that these side effects are “not rare” and cautioned that there is no clear advantage to using mesh implants over non-mesh methods for treating pelvic organ prolapse. The FDA has also asked transvaginal manufacturers to conduct post-market safety studies on the adverse effects associated with the devices.

Earlier this year, Johnson & Johnson stated that they would no longer sell the Prolift, Prolift + M, TVT Secur and Prosima transvaginal mesh.

About Public Health Watchdog
Public Health Watchdog is a media outlet created to provide consumers with up-to-date information about defective drugs and medical devices that could endanger their health. For more information on other dangerous drugs and medical devices, please visit Public Health Watchdog today.

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